Study Results
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View full resultsBasic Information
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COMPLETED
NA
202 participants
INTERVENTIONAL
2023-07-17
2025-02-17
Brief Summary
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Detailed Description
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Within 2 weeks the participant will return to the University where they will undergo the following protocol. Participants will be randomly assigned to one of 3 conditions that differ by who is with them in the scanner room: Primary Parent, Close Friend, No Social Partner. (N=50 per condition, 25 male, 25 female).
Once at the Center for Magnetic Resonance Research, participants and the individual who will be with the participant in the scanning room will undergo an MRI safety screening (the repeat of what was completed over the phone). Females will be shown to a changing room where the investigators will privately question them about any possibility of pregnancy. The participant will also have a chance to experience a simulated MRI in order to determine whether they will be comfortable in an actual MRI. Participants will be shown into the scanning control room and one more safety check will be performed before they enter the scanner room and the scanner. If they are in one of the social buffering conditions, the social buffering partner will also enter the scanning room and will sit to the side of the scanner.
The scanning bed will then be moved into the barrel of the MRI machine. The participant will be wearing head phones to protect his/her hearing and to receive instructions from the control room. The participant will then complete two emotionally evocative paradigms. The investigators will use a 3T Siemens Prisma scanner with a standard 32-channel phased array head coil.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
NONE
Study Groups
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Primary Parent
Participants will be randomly assigned to one of 3 conditions that differ by who is with them in the MRI scanner room: Primary Parent, Close Friend, No Social Partner.
In this case, the primary parent was present in the MRI room during the assessment.
Questionnaires
The participant will complete questionnaires, including ones on pubertal development and quality of relations with parents and friends.
MRI
Within 2 weeks of the first study visit, the participant will return to the University where they will undergo MRI.
Close Friend
Participants will be randomly assigned to one of 3 conditions that differ by who is with them in the MRI scanner room: Primary Parent, Close Friend,No Social Partner.
In this case, the close friend was present in the MRI room during the assessment.
Questionnaires
The participant will complete questionnaires, including ones on pubertal development and quality of relations with parents and friends.
MRI
Within 2 weeks of the first study visit, the participant will return to the University where they will undergo MRI.
No Social Partner
Participants will be randomly assigned to one of 3 conditions that differ by who is with them in the MRI scanner room: Primary Parent, Close Friend, No Social Partner.
In this case, no social partner was present in the MRI room during the assessment.
Questionnaires
The participant will complete questionnaires, including ones on pubertal development and quality of relations with parents and friends.
MRI
Within 2 weeks of the first study visit, the participant will return to the University where they will undergo MRI.
Interventions
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Questionnaires
The participant will complete questionnaires, including ones on pubertal development and quality of relations with parents and friends.
MRI
Within 2 weeks of the first study visit, the participant will return to the University where they will undergo MRI.
Eligibility Criteria
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Inclusion Criteria
* sufficient hearing to complete assent and study procedures
* sufficient language skills to provide verbal and written assent
Exclusion Criteria
* congenital and/or chromosomal disorders (e.g. cerebral palsy, FAS, mental retardation, Turner Syndrome, Down Syndrome, Fragile X)
* Autism Spectrum Disorders
* history of serious medical illness (e.g., cancer, organ transplant)
* youth taking systemic glucocorticoids
* youth taking beta-adrenergic medications
* diagnoses of psychiatric illness, seizure disorder or other neurological disorders
* contraindications for MRI (implanted medical device; presence of non-removal metal in or on the body, including piercings, orthodontic braces or certain permanent retainers)
* known pregnancy
* tattoos
* history of significant claustrophobia
11 Years
14 Years
ALL
Yes
Sponsors
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University of Minnesota
OTHER
Responsible Party
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Principal Investigators
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Megan Gunnar, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Minnesota
Kathleen Thomas, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Minnesota
Locations
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University of Minnesota
Minneapolis, Minnesota, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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STUDY00006378-2
Identifier Type: -
Identifier Source: org_study_id
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